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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

Perrigo Company PLC: Ranitidine (Acid Reducer) Recalled for Potential NDMA Contamination

Agency Publication Date: March 13, 2020
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Summary

Perrigo Company PLC has voluntarily recalled multiple lots of Regular and Maximum Strength Acid Reducer, Ranitidine tablets (generic Zantac), across various store brands like CVS Health, Walgreens, Equate, and Up & Up. The recall was initiated because the products may contain an impurity called N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen. These over-the-counter medications were distributed nationwide in the United States in various tablet counts and strengths ranging from 75 mg to 150 mg.

Risk

The tablets may contain NDMA, a substance that could increase the risk of cancer with long-term exposure. While no immediate injuries or adverse events were reported in the data, the presence of this impurity is a deviation from current Good Manufacturing Practices (cGMP).

What You Should Do

  1. Check your medicine cabinet for Regular Strength (75 mg) or Maximum Strength (150 mg) Ranitidine tablets sold under brands including CVS Health, Walgreens, Equate, Up & Up, Good Sense, HEB, Kroger, and Rite Aid.
  2. Compare the lot numbers on your bottle with the extensive list of affected lots, such as 8DE1363, 8EE1558, 8FE1450, 9GE3218, 9HE3577, and many others listed in the product details.
  3. Verify the NDC (National Drug Code) on the packaging, such as CVS Health 69842-293-65, Walgreens 0363-1876-65, or Equate 49035-876-47.
  4. Stop taking the affected medication and contact your healthcare provider or pharmacist for guidance on alternative acid-reducing treatments.
  5. Return any unused product to the pharmacy or retail store where it was purchased to request a refund.
  6. Contact Perrigo Company PLC at 1-888-723-3332 if you have questions regarding the recall or for instructions on how to return the product.
  7. For further consumer safety information, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy 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: Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg (30 tablets)
Model:
69842-293-65
41163-931-65
55319-876-65
0113-0876-65
37808-876-65
69256-876-65
62011-0283-1
0904-6715-46
21130-118-65
49348-136-44
11673-876-65
0363-1876-65
Lot Numbers:
8DE1363
8EE1558
8FE1450
8GE1331
8HE1221
8KE2825
8JE1916
8KE2243
8ME2685
9AE2785
9AE2786
9DE2721
9CE3317
9EE2579
9FE2957
9GE2785
9GE3218
9HE3577
Product: Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg (60 tablets)
Model:
62011-0283-2
0904-6715-52
41250-252-72
49348-136-12
Lot Numbers:
8DE1367
8EE1559
8FE1451
8GE1340
8HE1222
8KE2831
8JE1917
8KE2245
8ME2724
9AE2831
9DE2747
9CE3339
9EE2636
9FE2971
9GE2793
9GE3220
Product: Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg (80 tablets)
Model:
0113-7876-27
69842-293-27
70000-0375-2
11673-876-27
0363-1876-27
Lot Numbers:
8CE1643
8DE1370
8DE1768
8EE1560
8FE1452
8GE1341
8HE1223
8KE2832
8KE2246
8ME2725
9AE2835
9CE3378
9DE2748
9EE2637
9FE2976
9GE2795
9GE3228
9HE3617
Product: Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg (150 tablets)
Model:
37808-876-47
49035-876-47
Lot Numbers:
8CE1644
8CE1645
8DE1401
8DE1402
8DE1403
8DE1769
8DE1773
8EE1561
8EE1562
8FE1453
8FE1454
8GE1342
8HE1224
8KE2248
8KE2833
8JE1918
8KE2247
8ME2727
8ME2729
9DE2750
9AE2836
9AE2837
9CE3403
9CE3404
9DE2749
9EE2638
9FE2977
9GE2796
9GE3229
Product: Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg (160 tablets)
Model:
69842-293-06
Lot Numbers:
8FE1455
8GE1343
8HE1225
8KE2834
8KE2249
8ME2730
9AE2838
9EE2639
9FE2993
Product: Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg (8 tablets)
Model:
0113-0852-51
0363-0852-51
Lot Numbers:
8CE1429
8CE1760
9BE2907
9DE3183
9EE2900
9JE2936
Product: Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg (24 tablets)
Model:
46994-852-62
41520-392-02
59779-540-02
55910-852-02
41163-852-62
49035-608-02
55301-852-02
55319-852-02
46122-224-62
0113-0852-62
69256-041-62
49348-109-04
30142-600-02
0904-6716-24
41250-852-02
56062-099-02
11822-0852-5
10202-852-62
41190-852-62
37012-852-62
21130-116-02
50594-852-02
62011-0282-1
36800-852-02
11673-023-02
0363-0852-62
Lot Numbers (65):
8EE1452R
8AE1743
8BE1340
8CE1549
8CE1778
8DE1128
8DE1313
8DE1640
8EE1117
8EE1234
8EE1452
8CE1314
8CE1315
8DE1096
8DE1530
8EE1699
8GE1528
8HE1465
8JE2199
8LE2172
8DE1721
8EE1299
8FE1634
8GE1833
8GE1835
8HE1337
8LE2173
8LE2380
9BE2888
8JE2162
8KE2495
8KE2496
8LE2169
9BE2772
9BE2889
9CE3771
9DE2854
8LE2288
8LE2592
8LE2593
8ME3124
8ME3125
9BE2773
9BE2774
9DE3234
9EE2603
9EE2903
9FE2952
9CE3689
9CE3690
Product: Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg (24 tablets)
Model:
41520-609-62
59779-950-62
55910-423-62
41163-950-62
55319-523-62
46122-041-62
37808-710-02
30142-891-02
70000-0378-1
41250-950-02
11822-0950-0
37012-950-62
21130-568-62
36800-950-62
0363-0950-02
Lot Numbers:
8FV1462
8GV1289
8BE1465
8CE1616
8DE1277
8DE1580
8DE1766
8FE1348
8GE1527
8GE1733
8GE1735
8HE1466
8HE1590
8JE2232
8KE2676
8LE2283
8LE2284
8LE2345
8ME2640
9AE2663
9AE2863
9AE2864
9BE3158
9CE3773
9CE3774
9CE3879
9EE2499
9EE2635
9EE2904
9FE2821
9FE2953
9FE3369
9GE2653
9GE2905
9GE3077
9GE3115
9HE3546
9HE3559
9JE2593
Product: Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg (40 tablets)
Model:
11673-950-58
Lot Numbers:
9BE3161
9CE3880
9EE2500
9FE2823
9GE2656
9HE3554
9JE2676
Product: Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg (50 tablets)
Model:
55910-852-71
46122-224-71
0113-0852-71
69256-041-71
30142-600-71
0904-6716-51
41250-852-71
56062-099-71
11822-0852-2
21130-116-71
36800-852-71
Lot Numbers:
8AE1744
8BE1369
8CE1377
8CE1378
8DE1103
8DE1531
8EE1700
8FV0829
8DE1722
8EE1317
8FE1635
8GE1921
8HE1342
8KE2503R
8JE2154
8KE2503
8LE2198
8LE2597
9AE2499
9BE2862
9BE2863
9CE3723
9DE2890
9DE2891
9EE2812
9FE3187
9GE2885
9HE3435
9JE2656
Product: Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg (65 tablets)
Model:
41520-392-09
59779-540-09
55319-852-09
46122-532-09
37808-507-09
49348-109-54
41250-891-09
11822-0852-3
37012-852-09
50594-852-09
11673-852-09
0363-0852-09
Lot Numbers:
8AE1752
8BE1412
8CE1437
8CE1439
8DE1141
8DE1737
8EE1318
8FE1690
8GE1928
8HE1395
8JE2155
8KE2516
8LE2253
8LE2624
9AE2522
9BE2933
9BE2934
9CE3734
9DE3070
9EE2830
9FE3266
9GE2934
Product: Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg (65 tablets)
Model:
0113-7950-09
59779-950-09
49035-800-09
46122-533-09
30142-891-09
36800-950-09
11673-950-09
0363-0950-09
Lot Numbers:
8AE1884
8BE1466
8DE1318
8CE1617
8DE1319
8EE1326
8DE1611
8DE1767
8FE1350
8FE1352
8GE1736
8GE1840
8GE1859
8HE1592
8HE1593
8HE1594
8JE2234
9CE3263
8JE2233
8LE2360
8KE2704
8ME2641
8ME2642
9AE2675
9AE2676
9CE3265
9CE3881
9DE2585
9EE2501
9EE2502
9FE2825
9FE2827
9GE2657
9GE3124
9GE3122
9HE3555
Product: Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg (90 tablets)
Model:
49035-608-75
11673-023-75
Lot Numbers:
8EE1702
8EE1703
8EE1704
8FE1724
8GE1942
8HE1396
8HE1397
8JE2156
8KE2521
8KE2523
8LE2255
8LE2665
8LE2668
9AE2541
9AE2542
9AE2543
9BE2993
9BE2994
9BE2995
9CE3735
9CE3736
9DE3108
9DE3109
9DE3110
9EE2872
9EE2880
9FE3273
9FE3276
9GE2978
9GE2979
9HE3437
9HE3438
Product: Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg (90 tablets)
Model:
49035-800-75
11673-950-75
Lot Numbers:
8EE1514
8EE1515
8FE1353
8GE1732
8GE1864
8HE1652
8HE1653
8JE2235
8KE2724
8KE2725
8LE2367
8ME2643
8ME2644
9AE2766
9AE2767
9CE3273
9CE3274
9DE2629
9DE2630
9EE2516
9EE2517
9FE2915
9FE2916
9GE2694
9GE3144
Product: Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg (95 tablets)
Model:
0113-7852-01
68391-852-56
59779-540-01
55910-011-01
63981-852-56
30142-600-56
41250-852-01
11822-0852-4
0363-0852-01
Lot Numbers (109):
8CE1446
8DE1740
8FE1238
8FE1794
8GE1964
8JE2159
8ME2546
8ME2547
9BE3011
9CE3854
9DE3158
9FE3340
9HE3445
9JE2663
8AE1779
8BE1414
8DE1199
8DE1200
8DE1532
8EE1321
8FE1239
8FE1346
8FE1793
8HE1516
8KE2563
8KE2563R
8LE2260
9AE2610
9AE2612
9BE3012
9BE3013
9CE3852
9DE3156R
9DE3160
9DE3161
9EE2952
9FE3338
9GE2993
8AV1095
8AV1150
8AV1235
8AV1236
8AV1237
8BV0896
8BV0897
8BV0910
8BV1737
8BV1757
8BV1758
8CV0930
Product: Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg (95 tablets)
Model:
0113-7950-01
59779-950-01
Lot Numbers:
8BE1032
8BE1486
8CE1638
8DE1361
8DE1612
8FE1354
8GE1737
8HE1654
8JE2237
8KE2726
8LE2369
8ME2645
9AE2777
9CE3315
9DE2720
9EE2578
9FE2956
9GE2698
9GE3202
Product: Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg (200 tablets)
Model:
0113-7852-82
59779-540-82
37808-507-82
21130-116-82
0363-0852-82
Lot Numbers:
8AE1291
8AE1785
8BE1415
8CE1525
8DE1201
8DE1741
8EE1323
8FE1806
8GE1965
8HE1517
8JE2161
8KE2565
8LE2261
8ME2548
9AE2658
9BE3018
9CE3861
9DE3244
9FE2820
9FE3373
9GE3094
9HE3449
9JE2665

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84127
Status: Resolved
Manufacturer: Perrigo Company PLC
Sold By: CVS Health; Walgreens; Rite Aid; Walmart; Target; Kroger; Meijer; HEB; Publix; Harris Teeter; Shopko; Health Mart; Family Wellness; Leader; Sunmark; Good Sense; Equate; Up & Up; Care One; DG Health; Exchange Select; Good Neighbor Pharmacy; Signature Care; Berkley Jensen; Kirkland; Sound Body; Shop Rite; Select 7
Manufactured In: United States
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.

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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 ยท 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.