Medications & Supplements/Prescription Drugs

American Pharmaceutical Ingredients LLC: Various Prescription Compounding Ingredients Recalled for Lack of Stability Data

Agency Publication Date: February 22, 2018

Summary

Approximately 5.18 million units of over 50 different pharmaceutical ingredients used for prescription compounding, including Amitriptyline, Baclofen, Gabapentin, and various hormones, have been recalled. These products were distributed by American Pharmaceutical Ingredients LLC across the United States. The recall was initiated because the company lacks the necessary stability data and testing controls to support the expiration and retest dates assigned to these ingredients when stored in their specific container systems.

Risk

Without proper stability data, these pharmaceutical ingredients may lose their potency or degrade before their listed expiration date. This could result in patients receiving compounding medications that are ineffective or have an unpredictable chemical makeup, potentially failing to treat the medical conditions for which they were prescribed.

What You Should Do

Check your medication labels or contact your pharmacist to determine if your compounded prescription was made using ingredients from American Pharmaceutical Ingredients LLC.
Identify the specific ingredient and lot number on the original bulk container; for example, Amitriptyline HCl lot 031915-1, Gabapentin lot 031116-7, or Progesterone (Yam) lot 031115-3.
If you have an affected product, contact your healthcare provider or pharmacist immediately to discuss whether your medication is still safe to use or if a replacement is necessary.
Return any unused compounding ingredients to the place of purchase for a refund and contact American Pharmaceutical Ingredients LLC for further return instructions.
Pharmacists and compounding facilities should immediately stop using the affected lots and quarantine any remaining stock.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Return products for a refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Amitriptyline HCl USP for prescription compounding (25 g, 100 g, 500 g, 1000 g)

Model:

NDC 58597-8003-4

NDC 58597-8003-6

NDC 58597-8003-7

NDC 58597-8003-8

Lot Numbers:

031915-1 (Exp. 12/31/2019)

031915-2 (Exp. 12/31/2019)

Product: Anastrozole USP for prescription compounding (1 g, 5 g, 25 g)

Model:

NDC 58597-8080-1

NDC 58597-8080-2

NDC 58597-8080-4

Lot Numbers:

011116-1 (Exp. 07/31/2020)

011116-2 (Exp. 07/31/2020)

Product: Baclofen USP (Micronized) for prescription compounding (25 g, 100 g, 500 g, 1000 g)

Model:

NDC 58597-8004-4

NDC 58597-8004-6

NDC 58597-8004-7

NDC 58597-8004-8

Lot Numbers:

021816-1 (Exp. 08/24/2018)

021816-2 (Exp. 08/24/2018)

021816-3 (Exp. 08/24/2018)

70616-1 (Exp. 01/31/2019)

070616-1 (Exp. 01/31/2019)

Product: Gabapentin USP for prescription compounding (25 g, 100 g, 500 g, 1000 g)

Model:

NDC 58597-8014-4

NDC 58597-8014-6

NDC 58597-8014-7

NDC 58597-8014-8

Lot Numbers:

031116-7 (Exp. 03/31/2019)

112816-1 (Exp. 03/01/2020)

011717-2 (Exp. 04/30/2020)

051617-1 (Exp. 04/30/2020)

031116-1 (Exp. 03/31/2019)

031116-2 (Exp. 03/31/2019)

051215-1 (Exp. 03/05/2018)

063015-1 (Exp. 05/19/2018)

092315-1 (Exp. 07/17/2018)

111615-6 (Exp. 08/27/2018)

011717-7 (Exp. 04/30/2020)

082117B-1 (Exp. 04/30/2020)

031116-4 (Exp. 03/31/2019)

031116-5 (Exp. 03/31/2019)

092315-2 (Exp. 07/17/2018)

111615-4 (Exp. 08/27/2018)

111615-5 (Exp. 08/27/2018)

112816-2 (Exp. 03/01/2020)

031116-3 (Exp. 03/31/2019)

031116-6 (Exp. 03/31/2019)

051215-3 (Exp. 03/05/2018)

063015-2 (Exp. 05/19/2018)

111615-1 (Exp. 08/27/2018)

111615-2 (Exp. 08/27/2018)

111615-3 (Exp. 08/27/2018)

Product: Progesterone USP (Micronized) (Yam) for prescription compounding (1 g to 5000 g)

Model:

NDC 58597-8471-1

NDC 58597-8471-3

NDC 58597-8471-4

NDC 58597-8471-6

NDC 58597-8471-7

NDC 58597-8471-8

NDC 58597-8471-9

Lot Numbers:

031115-3 (Exp. 12/24/2019)

050815-3 (Exp. 04/14/2020)

010716-1 (Exp. 11/10/2018)

010716-6 (Exp. 11/10/2018)

030116-4 (Exp. 12/04/2018)

031115-2 (Exp. 12/24/2019)

060116-9 (Exp. 4/28/2019)

080416-1 (Exp. 06/05/2019)

080416-4 (Exp. 06/05/2019)

080615-4 (Exp. 07/29/2020)

112015-6 (Exp. 10/7/2018)

121916-7 (Exp. 11/10/2018)

080615-5 (Exp. 07/29/2020)

010716-4 (Exp. 11/10/2018)

010716-5 (Exp. 11/10/2018)

030116-2 (Exp. 12/04/2018)

031115-5 (Exp. 12/24/2019)

060116-1 (Exp. 04/28/2019)

060116-4 (Exp. 04/28/2019)

060116-5 (Exp. 04/28/2019)

080416-2 (Exp. 06/05/2019)

112015-1 (Exp. 10/07/2018)

121916-2 (Exp. 11/02/2019)

121916-3 (Exp. 11/02/2019)

121916-6 (Exp. 11/02/2019)

112015-5 (Exp. 10/07/2018)

030116-3 (Exp. 12/04/2018)

010716-2 (Exp. 11/10/2018)

010716-3 (Exp. 11/10/2018)

010716-8 (Exp. 11/10/2018)

030116-1 (Exp. 12/4/2018)

030116-5 (Exp. 12/4/2018)

060116-6 (Exp. 04/28/2019)

060116-8 (Exp. 04/28/2019)

080416-3 (Exp. 06/05/2019)

080416-5 (Exp. 06/05/2019)

112015-2 (Exp. 10/07/2018)

112015-3 (Exp. 10/07/2018)

112015-4 (Exp. 10/07/2018)

112015-7 (Exp. 10/07/2018)

121916-1 (Exp. 11/02/2019)

121916-4 (Exp. 11/02/2019)

121916-5 (Exp. 11/02/2019)

121916-8 (Exp. 11/02/2019)

060116-2 (Exp. 04/28/2019)

060116-3 (Exp. 04/28/2019)

060116-7 (Exp. 04/28/2019)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79149

Status: Resolved

Manufacturer: American Pharmaceutical Ingredients LLC

Sold By: American Pharmaceutical Ingredients LLC; Compounding pharmacies; Specialty healthcare providers

Manufactured In: United States

Units Affected: 63 products (15000 g; 684 g; 55500 g; 10 g; 48525 g; 1300 g; 5000 g; 123900 g; 13335 g; 116850 g; 8300 g; 75000; 10000 g; 2000 g; 4910 g; 3675 g; 5000 g; 106200 g; 193000 g; 606950; 26500 g; 1638 g; 52000 g; 191000 g; 4600 g; 225300 g; 240 g; 36100 g; 5800 g; 10000 g; 75 g; 166000 g; 74000 g; 22900 g; 73 g; 12000 g; 7000 g; 86225 g; 44500 g; 24025 g; 29550 g; 6000 g; 20700 g; 1,050,000 g; 307500 g; 12300 g; 10000 g; 10000 g; 75 g; 90000 g; 33000 g; 611400 g; 47500 g; 192000 g; 63975 g; 2100 g; 25000 g; 12725 g; 10000 g; 50000 g; 200000 g; 7255 g; 10769 g)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medication labels or contact your pharmacist to determine if your compounded prescription was made using ingredients from American Pharmaceutical Ingredients LLC.

Identify the specific ingredient and lot number on the original bulk container; for example, Amitriptyline HCl lot 031915-1, Gabapentin lot 031116-7, or Progesterone (Yam) lot 031115-3.

If you have an affected product, contact your healthcare provider or pharmacist immediately to discuss whether your medication is still safe to use or if a replacement is necessary.

Return any unused compounding ingredients to the place of purchase for a refund and contact American Pharmaceutical Ingredients LLC for further return instructions.

Pharmacists and compounding facilities should immediately stop using the affected lots and quarantine any remaining stock.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-SAFEFDA).

Affected Products

Product: Amitriptyline HCl USP for prescription compounding (25 g, 100 g, 500 g, 1000 g)

Model:

NDC 58597-8003-4

NDC 58597-8003-6

NDC 58597-8003-7

NDC 58597-8003-8

Lot Numbers:

031915-1 (Exp. 12/31/2019)

031915-2 (Exp. 12/31/2019)

Product: Anastrozole USP for prescription compounding (1 g, 5 g, 25 g)

Model:

NDC 58597-8080-1

NDC 58597-8080-2

NDC 58597-8080-4

Lot Numbers:

011116-1 (Exp. 07/31/2020)

011116-2 (Exp. 07/31/2020)

Product: Baclofen USP (Micronized) for prescription compounding (25 g, 100 g, 500 g, 1000 g)

Model:

NDC 58597-8004-4

NDC 58597-8004-6

NDC 58597-8004-7

NDC 58597-8004-8

Lot Numbers:

021816-1 (Exp. 08/24/2018)

021816-2 (Exp. 08/24/2018)

021816-3 (Exp. 08/24/2018)

70616-1 (Exp. 01/31/2019)

070616-1 (Exp. 01/31/2019)

Product: Gabapentin USP for prescription compounding (25 g, 100 g, 500 g, 1000 g)

Model:

NDC 58597-8014-4

NDC 58597-8014-6

NDC 58597-8014-7

NDC 58597-8014-8

Lot Numbers:

031116-7 (Exp. 03/31/2019)

112816-1 (Exp. 03/01/2020)

011717-2 (Exp. 04/30/2020)

051617-1 (Exp. 04/30/2020)

031116-1 (Exp. 03/31/2019)

031116-2 (Exp. 03/31/2019)

051215-1 (Exp. 03/05/2018)

063015-1 (Exp. 05/19/2018)

092315-1 (Exp. 07/17/2018)

111615-6 (Exp. 08/27/2018)

011717-7 (Exp. 04/30/2020)

082117B-1 (Exp. 04/30/2020)

031116-4 (Exp. 03/31/2019)

031116-5 (Exp. 03/31/2019)

092315-2 (Exp. 07/17/2018)

111615-4 (Exp. 08/27/2018)

111615-5 (Exp. 08/27/2018)

112816-2 (Exp. 03/01/2020)

031116-3 (Exp. 03/31/2019)

031116-6 (Exp. 03/31/2019)

051215-3 (Exp. 03/05/2018)

063015-2 (Exp. 05/19/2018)

111615-1 (Exp. 08/27/2018)

111615-2 (Exp. 08/27/2018)

111615-3 (Exp. 08/27/2018)

Product: Progesterone USP (Micronized) (Yam) for prescription compounding (1 g to 5000 g)

Model:

NDC 58597-8471-1

NDC 58597-8471-3

NDC 58597-8471-4

NDC 58597-8471-6

NDC 58597-8471-7

NDC 58597-8471-8

NDC 58597-8471-9

Lot Numbers:

031115-3 (Exp. 12/24/2019)

050815-3 (Exp. 04/14/2020)

010716-1 (Exp. 11/10/2018)

010716-6 (Exp. 11/10/2018)

030116-4 (Exp. 12/04/2018)

031115-2 (Exp. 12/24/2019)

060116-9 (Exp. 4/28/2019)

080416-1 (Exp. 06/05/2019)

080416-4 (Exp. 06/05/2019)

080615-4 (Exp. 07/29/2020)

112015-6 (Exp. 10/7/2018)

121916-7 (Exp. 11/10/2018)

080615-5 (Exp. 07/29/2020)

010716-4 (Exp. 11/10/2018)

010716-5 (Exp. 11/10/2018)

030116-2 (Exp. 12/04/2018)

031115-5 (Exp. 12/24/2019)

060116-1 (Exp. 04/28/2019)

060116-4 (Exp. 04/28/2019)

060116-5 (Exp. 04/28/2019)

080416-2 (Exp. 06/05/2019)

112015-1 (Exp. 10/07/2018)

121916-2 (Exp. 11/02/2019)

121916-3 (Exp. 11/02/2019)

121916-6 (Exp. 11/02/2019)

112015-5 (Exp. 10/07/2018)

030116-3 (Exp. 12/04/2018)

010716-2 (Exp. 11/10/2018)

010716-3 (Exp. 11/10/2018)

010716-8 (Exp. 11/10/2018)

030116-1 (Exp. 12/4/2018)

030116-5 (Exp. 12/4/2018)

060116-6 (Exp. 04/28/2019)

060116-8 (Exp. 04/28/2019)

080416-3 (Exp. 06/05/2019)

080416-5 (Exp. 06/05/2019)

112015-2 (Exp. 10/07/2018)

112015-3 (Exp. 10/07/2018)

112015-4 (Exp. 10/07/2018)

112015-7 (Exp. 10/07/2018)

121916-1 (Exp. 11/02/2019)

121916-4 (Exp. 11/02/2019)

121916-5 (Exp. 11/02/2019)

121916-8 (Exp. 11/02/2019)

060116-2 (Exp. 04/28/2019)

060116-3 (Exp. 04/28/2019)

060116-7 (Exp. 04/28/2019)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79149

Status: Resolved

Manufacturer: American Pharmaceutical Ingredients LLC

Sold By: American Pharmaceutical Ingredients LLC; Compounding pharmacies; Specialty healthcare providers

Manufactured In: United States

Distributed To: Nationwide