Pfizer Recalls Diphenoxylate and Atropine Tablets Due to Potency Variations
Pfizer is recalling specific lots of diphenoxylate hydrochloride and atropine sulfate tablets because weight variations caused some tablets to be sub-potent or super-potent.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of at least 4 according to the rubric, as it involves a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Pfizer Inc. is recalling 183,437 bottles of diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg. The affected products are distributed nationwide in the USA and are available in 100-count and 1,000-count bottles. The recall is limited to specific lot numbers with expiration dates in October and November 2021.
The recall was initiated because weight variations in the tablets resulted in some being sub-potent (containing less active ingredient than labeled) and others being super-potent (containing more active ingredient than labeled). This deviation from the required potency specifications poses a risk to patients relying on the medication for consistent therapeutic effects.
Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product matches the recalled lots, it should be discontinued and returned to the pharmacy or supplier for credit. Patients should consult their healthcare provider for alternative treatment options if they are currently using the affected medication.
The recalled product
- Product
- DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE (DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE)
- Brand
- DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 183,437
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Lots: a) R83962
- R93347
- R93348
- R93349
- R93350
- R93351
- R93352
- Exp. 2021 OCT 31
- S57831
- S57832
- S57834
- Exp. 2021 NOV 30 b) R93356
- R93357
- R93358
- R97310
- Exp. 2021 OCT 31.
UPCs (1)
- 0359762106117
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Pfizer Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Pfizer Inc.
See all →- HighSodium bicarbonate injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighEpinephrine injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighBicillin L-A 2.4 million unit vials recalled after particulates found
FDA (Drugs) · 2025-08-06
- HighBicillin L-A penicillin vials recalled after particulates found during visual inspection
FDA (Drugs) · 2025-08-06
- ModerateDobutamine Injection Recall Due to Discoloration and Cracked Vials
FDA (Drugs) · 2025-07-02
Same hazard · potency variation
See all →- HighFDA Recalls Levothyroxine Sodium Tablets for Potency Variation
FDA (Drugs) · 2024-12-18
- HighLevothyroxine Sodium Tablets Recalled for Potency Variation and Dosage Failures
FDA (Drugs) · 2024-12-18
- LowTeligent Pharma Recalls Clobetasol Propionate Ointment Due to Potency Issues
FDA (Drugs) · 2020-12-09
- SeverePharMEDium Recalls Hydromorphone Syringes Due to Potency Issues
FDA (Drugs) · 2018-06-20
- SeverePfizer Recalls Zoloft Tablets Due to Weight Variations
FDA (Drugs) · 2018-01-10